[Remote] eCOA - Clinical Study Build Programmer

Note: The job is a remote job and is open to candidates in USA. Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving lives through innovative medicines. The Clinical Study Build Programmer - eCOA is responsible for programming and testing clinical trial data collection databases, ensuring accurate data collection methods and collaboration with various data colleagues for successful clinical trials.ResponsibilitiesProficiency in programming and configuring clinical data collection systems (e.g., eCOA/EDC platforms)Study build programming expertise (e.g., form logic, edit checks, workflows, integrations)Program and test data collection systems and associated data repository mappings for a trial or set of trials within a program using data standards library componentsGather and influence eCOA design specifications and enable successful implementationUnderstand study translation needs and enable localizationEnsure data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectivesProvide insights into the study design and data delivery (i.e. Data Management Plan, Project Plan, database, and observed datasets)Support submission, inspection and regulatory response activitiesLead cross Business Unit/Therapeutic Area projects or programs with high complexityPossess a deep understanding of the technology used to collect clinical trial dataDevelops and tests new ideas and/or applies innovative solutionsIncrease speed, accuracy, and consistency in the development of systems solutionsEnable metrics reporting of study development timelines and pre and post production changes to databasePartner with Data and Analytics colleagues such as the Clinical Data Associate, Clinical Data Management Associate to deliver study database per business need and before first patient visitInfluence data standard decisions and strategies for a study and/or programEffectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to study database buildingIntegrates multi-functional, external information and technical knowledge to support data-driven decision makingContinually seek and implement means of improving processes to reduce study build cycle time, decrease work effort and enable the normalization of various sources of data into a common data repository in a way that allows for improved integration, consumption and downstream analysisWork to reduce postproduction changes change control processAnticipate and resolve key technical, operational or business problems that impact the Data and Analytics organizationThinks with end to end in mind consistently managing risk to minimize impact on deliveryStrong awareness with external developments, timelinesFocuses on defining database solutions and timelines in support of advancing the portfolioSkillsMaster's degree in a scientific field such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, Computer Sciences+ 3 years of related experience (or bachelor's degree plus 5 or more years of experience in clinical data management or areas that closely intersect with clinical data management e.g., statistics, data analytics, information technology, health outcomes, etc...)Proficiency in programming and configuring clinical data collection systems (e.g., eCOA/EDC platforms)Study build programming expertise (e.g., form logic, edit checks, workflows, integrations)Program and test data collection systems and associated data repository mappings for a trial or set of trials within a program using data standards library componentsGather and influence eCOA design specifications and enable successful implementationUnderstand study translation needs and enable localizationEnsure data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectivesProvide insights into the study design and data delivery (i.e. Data Management Plan, Project Plan, database, and observed datasets)Support submission, inspection and regulatory response activitiesLead cross Business Unit/Therapeutic Area projects or programs with high complexityPossess a deep understanding of the technology used to collect clinical trial dataDevelops and tests new ideas and/or applies innovative solutionsIncrease speed, accuracy, and consistency in the development of systems solutionsEnable metrics reporting of study development timelines and pre and post production changes to databasePartner with Data and Analytics colleagues such as the Clinical Data Associate, Clinical Data Management Associate to deliver study database per business need and before first patient visitInfluence data standard decisions and strategies for a study and/or programEffectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to study database buildingIntegrates multi-functional, external information and technical knowledge to support data-driven decision makingContinually seek and implement means of improving processes to reduce study build cycle time, decrease work effort and enable the normalization of various sources of data into a common data repository in a way that allows for improved integration, consumption and downstream analysisWork to reduce postproduction changes change control processAnticipate and resolve key technical, operational or business problems that impact the Data and Analytics organizationThinks with end to end in mind consistently managing risk to minimize impact on deliveryStrong awareness with external developments, timelinesFocuses on defining database solutions and timelines in support of advancing the portfolioExperience with designing and handling eCOA data Articulating the flow of data (structure and format) from patient to analysis, applying this knowledge to data solutionsDeciding the technology platform (system/database) for data acquisition and aggregation Utilization of clinical/drug development knowledge and an ability to liaise with study team members (i.e. Data Sciences, Statistics, PK, Operations, Medical, etc.)Strong therapeutic/scientific knowledge in the field of research Familiarity with clinical data tools and technologiesUnderstanding and experience in using data standards Ability to balance multiple activities, prioritize and manage ambiguityDomestic and International travel may be requiredBenefitsFull-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).Eligibility to participate in a company-sponsored 401(k)PensionVacation benefitsEligibility for medical, dental, vision and prescription drug benefitsFlexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)Life insurance and death benefitsCertain time off and leave of absence benefitsWell-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)Company OverviewWe're a medicine company turning science into healing to make life better for people around the world. It was founded in 1876, and is headquartered in Indianapolis, Indiana, USA, with a workforce of 10001+ employees. Its website is https://www.lilly.com.Company H1B SponsorshipEli Lilly and Company has a track record of offering H1B sponsorships, with 76 in 2026, 514 in 2025, 236 in 2024, 167 in 2023, 133 in 2022, 57 in 2021, 52 in 2020. Please note that this does not guarantee sponsorship for this specific role.